Vascular model

Abstract

This invention provides a vascular model that can simulate the increased local resistance caused by lesions during the insertion of long medical devices. [Solution] The blood vessel model 10 is a blood vessel model 10 having a passage 11 that simulates a blood vessel, wherein the inner circumferential surface 12 of the passage 11 located inside the bend 13 where the passage 11 curves from the upstream side to the downstream side has a rough surface portion 33 that has more convex portions 34 and / or concave portions per unit area compared to the inner circumferential surface 12 of the passage in other parts.

Description

Technical Field

[0001] The present invention relates to a blood vessel model that simulates blood vessels.

Background Art

[0002] In recent years, interventions have been performed to treat lesions occurring in blood vessels by percutaneously inserting long medical devices such as catheters and guidewires into the blood vessels. In the intervention, it is required that the medical device can reach the target position through the complexly bent blood vessels. For this reason, a blood vessel model that simulates blood vessels is used for evaluating the operability of the medical device and training the skills of the operator (see, for example, Patent Document 1).

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] By the way, in blood vessels, it is known that lesions such as thrombi and plaques are likely to occur in parts where blood flow is likely to stagnate. At the site where a lesion has occurred in the blood vessel, the resistance when pushing forward a long medical device such as a catheter or a guidewire increases. However, the blood vessel model described in Patent Document 1 does not have a structure that simulates the increase in resistance due to lesions during the insertion of the medical device.

[0005] The present invention has been made to solve the above-described problems, and an object thereof is to provide a blood vessel model that can simulate the increase in local resistance due to lesions during the insertion of a long medical device.

Means for Solving the Problems

[0006] The above objective is achieved by the invention described in (1) below. (1) The blood vessel model according to the present invention is a blood vessel model having passages that simulate blood vessels, wherein the passage has a rough surface portion on the inner surface of the passage in the portion located inside the curve where the passage bends from the upstream side to the downstream side, or on the upstream inner surface of the passage near the portion where the flow cross-sectional area of ​​the passage decreases, which has a larger number of convex and / or concave portions per unit area compared to the inner surface of the passage in other portions. [Effects of the Invention]

[0007] The vascular model described in (1) above has roughened areas in the blood vessels that increase resistance to long medical devices, corresponding to areas where blood flow is prone to stagnation and lesions are likely to occur. Therefore, the vascular model can simulate the increase in local resistance due to lesions when inserting long medical devices.

[0008] (2) In the vascular model described in (1) above, the curved portion of the passage includes a branching portion where a main passage simulating a main vessel and a branching passage extending away from the main passage communicate, and the roughened portion may be formed on the inner circumferential surface of the passage located downstream from the branching portion and inside the curved portion. This makes it possible to evaluate and train the vascular model by placing the roughened portion, which increases resistance to long medical devices, at locations corresponding to areas in branched vessels where blood flow is prone to stagnation and lesions are likely to occur.

[0009] (3) In the vascular model described in (1) or (2) above, the rough surface may have a plurality of substantially hemispherical protrusions. This allows the vascular model to increase its resistance due to the plurality of protrusions.

[0010] (4) In the blood vessel model described in any one of (1) to (3) above, the number of convex and / or concave parts formed on the rough surface per unit area is 2 / mm 2 ~40 pieces / mm 2This may also be the case. This allows the vascular model to approximate the resistance to long medical devices to the resistance caused by lesions in the blood vessels. [Brief explanation of the drawing]

[0011] [Figure 1] This is a plan view showing a vascular model according to the first embodiment. [Figure 2] This is a cross-sectional view along line AA in Figure 1. [Figure 3] This is a plan view showing a vascular model according to the second embodiment. [Figure 4] This is a plan view showing a vascular model according to the third embodiment. [Modes for carrying out the invention]

[0012] Embodiments of the present invention will be described below with reference to the drawings. Note that the dimensions in the drawings may be exaggerated for illustrative purposes and may differ from the actual dimensions. Furthermore, in this specification and the drawings, components having substantially the same function are denoted by the same reference numerals to avoid redundant explanations.

[0013] <First Embodiment> The vascular model 10 according to the first embodiment is a model that simulates blood vessels and is used for evaluating the operability of long medical devices such as catheters and guidewires, and for training operators' surgical techniques.

[0014] As shown in Figures 1 and 2, the blood vessel model 10 is formed in a plate shape and has a passage 11 with an inner circumferential surface 12 between its two surfaces in the thickness direction. The passage 11 has one main passage 20 that simulates a main blood vessel and at least one branch passage 30 that simulates branch blood vessels branching off from the main blood vessel.

[0015] The main passage 20 has a first opening 21 and a second opening 22 that open to the outside, and extends linearly between the first opening 21 and the second opening 22 with a constant inner diameter. The first opening 21 and the second opening 22 are formed on the side end faces of the blood vessel model 10. The first opening 21 simulates the upstream side of blood flow, and the second opening 22 simulates the downstream side of blood flow. The inner diameter of the main passage 20 is, for example, 1 mm to 20 mm. The inner diameter of the main passage 20 may change from the first opening 21 to the second opening 22. Also, the main passage 20 may be curved rather than linear.

[0016] Each of the branch passages 30 extends from a branching section 31 communicating with the main passage 20, in a direction away from the main passage 20 at a predetermined branching angle θ, and opens to the outside of the blood vessel model 10 at a third opening 32. The branching angle θ of the branch passages 30 (see Figure 1) is preferably between 30 and 150 degrees. Each of the branch passages 30 extends linearly from the branching section 31 to the third opening 32 with a constant inner diameter. The inner diameter of the branch passages 30 is preferably less than or equal to the inner diameter of the main passage 20. The inner diameter of the branch passages 30 may change from the main passage 20 towards the third opening 32. Also, the branch passages 30 may be curved rather than linear.

[0017] The passage 11 has a bent portion 13 that bends from the main passage 20 to the branch passage 30 through the branch portion 31 from the upstream first opening 21 toward the downstream second opening 22. The passage 11 has a rough surface portion 33 on the inner peripheral surface 12 of the passage located inside the bent portion 13. The rough surface portion 33 is formed on the inner peripheral surface 12 of the passage that is located downstream from the branch portion 31 of the passage 11 and inside the bent portion 13. That is, the rough surface portion 33 is formed on the inner peripheral surface of the branch passage 30 that is located inside the bent portion 13. On the other hand, the rough surface portion 33 is not formed on the inner peripheral surface 12 of the passage located outside the bent portion 13 of the passage 11. Therefore, in a cross-section perpendicular to the direction in which the branch passage 30 (passage 11) extends, the angle α (see FIG. 2) of the range where the rough surface portion 33 is formed on the inner peripheral surface 12 of the passage is less than 360 degrees including the inside of the bent portion 13, preferably 180 degrees or less including the inside of the bent portion 13, more preferably 90 degrees or less including the inside of the bent portion 13. The rough surface portion 33 is preferably formed in the range of 1 mm to 20 mm in the length L (see FIG. 1) along the direction from the branch portion 31 toward the third opening 32.

[0018] The position of the rough surface portion 33 in the passage 11 is a position where the flow of the fluid is likely to stagnate when the fluid flows through the passage 11 from the upstream side to the downstream side. The position where the blood flow is likely to stagnate in the blood vessel is a position where lesions such as thrombus and plaque are likely to be formed.

[0019] Each of the plurality of branch passages 30 preferably has a different inner diameter and a different branch angle θ, but is not limited thereto.

[0020] The material forming the blood vessel model 10 is, for example, silicone resin, urethane resin, or vinyl alcohol (PVA) resin.

[0021] The roughened surface 33 has a plurality of protrusions 34. The roughened surface 33 may also have a plurality of recesses. Alternatively, the roughened surface 33 may have both protrusions 34 and recesses. The shape of the protrusions 34 is generally hemispherical with a smooth top, but its shape is not limited. Note that the generally hemispherical shape includes not only the shape of a hemisphere cut by a plane passing through the center of a sphere, but also shapes that are slightly larger or slightly smaller than a hemisphere.

[0022] As a variation, the shape of the convex and / or concave portions may be, for example, a wave shape in which multiple convex and concave portions are alternately arranged and smoothly connected from the branch portion 31 of the branch passage 30 toward the third opening 32. In the wave shape, the convex portions are formed as ridges extending in the circumferential direction of the branch passage 30, and the concave portions are formed as grooves extending in the circumferential direction of the branch passage 30. The wave shape may be formed in both the convex and concave portions, or in only one of them.

[0023] The number of protrusions 34 and / or recesses per unit area is, for example, 2 / mm². 2 ~40 pieces / mm 2 The maximum height of the protrusions 34 of the roughened surface 33 is, for example, 0.05 mm to 0.5 mm. The maximum height of the protrusions 34 of the roughened surface 33 is, for example, 0.25% to 50% of the inner diameter of the passage 11 at the location where the roughened surface 33 is formed. The maximum depth of the recesses of the roughened surface 33 is, for example, 0.05 mm to 0.5 mm.

[0024] Next, the method of using the vascular model 10 according to the first embodiment will be described. The vascular model 10 is used with the passage 11 filled with water, physiological saline, or an aqueous solution containing a surfactant. The user inserts a long medical device into the main passage 20 through the first opening 21 or the second opening 22, and then into one of the branch passages 30 that simulate branched blood vessels. When the medical device comes into contact with the rough surface 33 of the branch passage 30, it receives high resistance from the convex 34 and / or concave parts of the rough surface 33. Therefore, the user can evaluate the operability of a long medical device in a diseased blood vessel and train the operator's technique.

[0025] Next, a method for manufacturing the blood vessel model 10 according to the first embodiment will be described. First, a mold is created that simulates the desired blood vessel pathway. The method of creating the mold is not particularly limited, but for example, it can be created from 3D data using a 3D printer. The material of the mold is not particularly limited, but resin, gel, or metal can be used.

[0026] Next, with the mold placed inside the container, a hardening agent (for example, silicone resin, urethane resin, or polyvinyl alcohol (PVA) resin) is poured in and allowed to harden to create the blood vessel model 10. Then, the internal mold is destroyed by external pressure or water pressure on the blood vessel model 10, and the model is pushed out and removed. This completes the blood vessel model 10, which has a space inside that simulates the course of blood vessels.

[0027] The roughened surface 33 of the blood vessel model 10 can be easily formed during the manufacturing process by creating convex and / or concave portions at corresponding positions on the mold.

[0028] As described above, the vascular model 10 according to the first embodiment is a vascular model 10 having a passage 11 that simulates a blood vessel, wherein the passage 11 has a rough surface 33 on the inner circumferential surface 12 of the passage located inside the curved portion 13 where the passage 11 bends from the upstream side to the downstream side, which has more convex portions 34 and / or concave portions per unit area compared to the inner circumferential surface 12 of the passage in other parts. As a result, the vascular model 10 has a rough surface 33 that increases resistance to long medical devices at locations corresponding to areas in the blood vessel where blood flow is likely to stagnate and lesions are likely to occur. Therefore, the vascular model 10 can simulate the increase in local resistance due to lesions when inserting a medical device.

[0029] Furthermore, the curved section 13 of the passage 11 includes a branching section 31 where a main passage 20, which simulates a main blood vessel, and a branched passage 30, which branches off and extends away from the main passage 20, communicate. The roughened section 33 is formed on the inner circumferential surface 12 of the passage, located downstream from the branching section 31 of the passage 11 and inside the curved section 13. This allows the vascular model 10 to perform evaluations and training by positioning the roughened section 33, which increases resistance to long medical devices, at locations corresponding to areas in branched blood vessels where blood flow is prone to stagnation and lesions are likely to occur.

[0030] Furthermore, the roughened surface 33 has a plurality of substantially hemispherical protrusions 34. As a result, the vascular model 10 can increase its resistance to long medical devices due to the plurality of protrusions 34.

[0031] Furthermore, the number of protrusions 34 and / or recesses formed on the rough surface 33 per unit area is 2 to 40 per mm. 2 Therefore, the vascular model 10 can approximate the resistance to long medical devices to the resistance caused by lesions in the blood vessels.

[0032] <Second Embodiment> The blood vessel model 40 according to the second embodiment differs from the first embodiment in that, as shown in Figure 3, the curved portion 44 has a smoothly curving passage 41 without branching.

[0033] The blood vessel model 40 is formed in a plate shape and has a passage 41 between its two surfaces in the thickness direction, with an inner circumferential surface 46 for the passage. The passage 41 has a first opening 42 and a second opening 43 that open to the outside, and extends between the first opening 42 and the second opening 43 with a constant inner diameter. The first opening 42 and the second opening 43 are formed on the side end faces of the blood vessel model 40. The first opening 42 simulates the upstream side of blood flow, and the second opening 43 simulates the downstream side of blood flow. The inner diameter of the passage 41 is, for example, 1 mm to 20 mm. The inner diameter of the passage 41 may change from the first opening 42 to the second opening 43.

[0034] The passage 41 has at least one smoothly curved bend 44 extending from the first opening 42 on the upstream side to the second opening 43 on the downstream side. As shown in Figure 3, the passage 41 has a plurality of bends 44 that curve in an arc shape with a substantially constant inner diameter and a predetermined radius of curvature R. The passage 41 has roughened surfaces 45 on the inner circumferential surface 46 of the passage located inside each bend 44. The locations of the roughened surfaces 45 in the passage 41 are positions where the fluid flow is likely to stagnate when the fluid flows through the passage 41 from the upstream side to the downstream side. The roughened surfaces 45 are formed at the apex of the bend 44 and in the region downstream of the apex. The apex of the bend 44 is the position on the inner circumferential surface 46 of the passage located inside the bend 44, in a cross-section including the long axis of the bend 44, that is furthest from the straight line connecting the upstream end and the downstream end of the inner circumferential surface 46 of the passage located inside the bend 44 in the perpendicular direction. Alternatively, the apex of the curved portion 44 may be the position in the cross-section including the major axis of the curved portion 44 where the radius of curvature R of the inner circumferential surface 46 of the passage located inside the curved portion 44 is smallest. On the other hand, the roughened portion 45 is not formed on the inner circumferential surface 46 of the passage 41 located outside the curved portion 44. The shape of the convex portion 34 and / or concave portion formed on the roughened portion 45 is the same as in the first embodiment. The radius of curvature R of the curvature of the curved portion 44 is preferably 1 mm to 40 mm.

[0035] Next, the method of using the vascular model 40 according to the second embodiment will be described. The user inserts a long medical device into the passage 41 through the first opening 42 or the second opening 43. When the medical device comes into contact with the rough surface 45 of the curved portion 44, it receives high resistance from the convex portions 34 and / or concave portions of the rough surface 45. Therefore, the user can evaluate the operability of the long medical device in a diseased blood vessel and train the operator's technique.

[0036] As described above, in the vascular model 40 according to the second embodiment, the curved portion 44 of the passage 41 curves smoothly. This allows the vascular model 40 to perform evaluation and training by positioning roughened portions 45 that increase resistance to long medical devices at locations corresponding to areas in curved blood vessels where blood flow is prone to stagnation and lesions are likely to occur.

[0037] <Third Embodiment> The blood vessel model 50 according to the third embodiment differs from the first and second embodiments in that, as shown in Figure 4, it has a passage 51 which includes a portion in which the flow path cross-sectional area is reduced.

[0038] The blood vessel model 50 is formed in a plate shape and has a passage 51 between its two surfaces in the thickness direction, the passage having an inner circumferential surface 58. The passage 51 has a first opening 52 and a second opening 53 that open to the outside, and has at least one reduced diameter section 54 between the first opening 52 and the second opening 53 where the inner diameter decreases. The passage 51 has a first tapered section 55 on the first opening 52 side of the reduced diameter section 54, where the inner diameter increases tapered toward the first opening 52, and a second tapered section 56 on the second opening 53 side of the reduced diameter section 54, where the inner diameter increases tapered toward the second opening 53. The parts of the passage 51 other than the reduced diameter section 54, the first tapered section 55 and the second tapered section 56 are formed linearly with a constant inner diameter, but they do not have to be constant and may be curved. The first opening 52 and the second opening 53 are formed on the side end faces of the blood vessel model 50. The first opening 52 simulates the upstream side of blood flow, and the second opening 53 simulates the downstream side of blood flow. The inner diameter of the narrowed portion 54 of the passage 51 is, for example, 0.01 mm to 14 mm. Note that the passage 51 does not necessarily have a first tapered portion 55 and / or a second tapered portion 56. In this case, the inner diameter of the passage 51 adjacent to the narrowed portion 54 may change in a stepped manner rather than tapered.

[0039] The passage 51 has a roughened surface 57 on the upstream inner circumferential surface 58 of the passage (in this embodiment, the inner circumferential surface 58 of the first tapered section 55) near the narrowed diameter section 54 where the flow path cross-sectional area decreases, from the upstream first opening 52 toward the downstream second opening 53. The location of the roughened surface 57 is a position where the fluid flow is likely to stagnate when the fluid flows through the passage 51 from the upstream side toward the downstream side. The roughened surface 57 is formed in the region of the passage 51 from the upstream side of the first tapered section 55 toward the narrowed diameter section 54. The roughened surface 57 is formed over the entire circumferential direction of the passage 51, but may be formed partially, as in the first and second embodiments. The shape of the convex portions 34 and / or concave portions formed on the roughened surface 57 is the same as in the first embodiment.

[0040] Next, the method of using the vascular model 50 according to the third embodiment will be described. The user inserts a long medical device into the passage 51 through the first opening 52 or the second opening 53 and brings it to the vicinity of the narrowed section 54, which simulates a blood vessel with a decreasing inner diameter. When the medical device comes into contact with the rough surface 57, it receives high resistance from the convex 34 and / or concave parts of the rough surface 57. Therefore, the user can evaluate the operability of the long medical device in a blood vessel with a lesion and train the operator.

[0041] As described above, the vascular model 50 according to the third embodiment is a vascular model 50 having a passage 51 that simulates a blood vessel, and the inner circumferential surface 58 of the passage 51 on the upstream side near the portion where the flow path cross-sectional area of ​​the passage 51 decreases has a rough surface portion 57 that has more convex portions 34 and / or concave portions per unit area compared to the inner circumferential surface 58 of the passage in other portions. As a result, the vascular model 50 has a rough surface portion 57 that increases resistance to long medical devices at a position corresponding to a site in a blood vessel where the inner diameter decreases and blood flow tends to stagnate and lesions tend to occur. For this reason, the vascular model 50 can simulate the resistance due to lesions when inserting a medical device in a manner that approximates that of an actual blood vessel.

[0042] It should be noted that the present invention is not limited to the embodiments described above, and various modifications can be made by those skilled in the art within the technical framework of the present invention. For example, the positions where rough surfaces are placed in the blood vessel model, i.e., positions where fluid flow tends to stagnate, may be identified as positions where the shear stress exerted by blood flow on the blood vessel is low, calculated by 3D blood flow analysis or the like. Alternatively, the positions where rough surfaces are placed in the blood vessel model, i.e., positions where fluid flow tends to stagnate, may be visually identified as positions where the color is darker when a colored liquid is actually circulated through the passages of the blood vessel model. Furthermore, although the blood vessel models 10, 40, and 50 according to the first to third embodiments are simplified models, the blood vessel models may have a 3D shape that is closer to that of actual blood vessels. [Explanation of symbols]

[0043] 10, 40, 50 Vascular Models Aisles 11, 41, and 51 12, 46, 58 Inner surface of passage 20 Main aisle 21, 42, 52 First opening 22, 43, 53 Second opening 30 Branching Passages 31 Branching point 32 Third opening 33, 45, 57 Rough surface area 34 Convex part 13, 44 curved section 54 Reduced diameter part

Claims

1. A vascular model having passages that simulate blood vessels, The blood vessel model is characterized in that the passage has a rough surface on the inner circumferential surface of the portion of the passage located inside the bend where the passage curves from the upstream side to the downstream side, or on the upstream inner circumferential surface of the passage near the portion where the flow cross-sectional area of ​​the passage decreases, with a greater number of convex and / or concave portions per unit area compared to the inner circumferential surface of other portions of the passage.

2. The curved portion of the passage includes a branching portion in which a main passage simulating a main blood vessel and a branching passage extending in a direction away from the main passage communicate with each other. The blood vessel model according to claim 1, characterized in that the roughened portion is formed on the inner circumferential surface of the passage located downstream from the branching portion of the passage and inside the curved portion.

3. The blood vessel model according to claim 1 or 2, characterized in that the roughened surface portion has a plurality of substantially hemispherical protrusions.

4. The number of protrusions and / or recesses formed on the roughened surface per unit area is 2 per mm. ２ ~40 pieces / mm ２ The vascular model according to claim 1 or 2, characterized in that it is the same as the one described above.

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